| [Objective]Obtain cut-off values of β-HCG,E2 and P levels for the prediction of embryo damage during early pregnancy,and explore the correlation between TCM syndrome elements and pregnancy outcome,thus optimizing the clinical diagnosis and treatment scheme of threatened abortion.[Methods]From January 2021 to January 2022,285 patients with threatened abortion hospitalized in the Department of TCM Gynaecology,Hangzhou Municipal Hospital of Traditional Chinese Medicine,for the prevention of miscarriage were selected according to the inclusion and exclusion criteria.Medical data were recorded,including general information,past medical history and β-HCG,E2 and P levels in early pregnancy,and standardized information from the four clinic diagnostic of TCM was collected in the form of questionnaire.In addition,patients in the early pregnancy were followed up to observe the pregnancy outcome,and then divided into pregnancy continuation group and pregnancy loss group according to the early pregnancy outcome.SPSS 25.0 software was used for statistical analysis on the collected data.The value and the cut-off value of β-HCG,E2 and P levels in early pregnancy were evaluated for predicting the pregnancy outcome.The distribution characteristics of TCM syndrome elements in the early pregnancy of patients with threatened abortion were explored,and the correlation between the TCM syndrome elements and the pregnancy outcome were further investigated.[Results]1.There was a significant difference in the gestational age between the pregnancy continuation group and the pregnancy loss group（P=0.000<0.05）.With the increase of age,the pregnancy loss rate increased gradually,and a rapid increase in the pregnancy loss rate was found in patients≥35 years old.2.There was no significant difference in menstrual history between the pregnancy continuation group and the pregnancy loss group（P>0.05）.3.There was no significant difference in previous delivery history between the pregnancy continuation group and the pregnancy loss group（P>0.05）;and no significant difference was found in the overall distribution of the number of previous abortions between the pregnancy continuation group and the pregnancy loss group（P>0.05）,but there was a significant difference in the early pregnancy outcome between the population with the number of previous abortions ≤2 and the population with the number of abortions≥ 3（P=0.034<0.05）.4.There was a significant difference in pregnancy mode between the pregnancy continuation group and the pregnancy loss group regarding the early pregnancy outcome（P=0.002<0.05）.Natural pregnancy showed a higher success rate in preventing miscarriage.5.In the early pregnancy,there was a significant difference in β-HCG level between the pregnancy continuation group and the pregnancy loss group.When the serum β-HCG level<5,000IU/L,there was a significant difference in β-HCG doubling number at alternate days in patients with different pregnancy outcomes.If alternate-day β-HCG doubl 210%as the cut-off value for predicting the pregnancy outcome,showing a high diagnostic value,with sensitivity,specificity and AUC being 77.8%,81.6%and 0.837,respectively;when the alternate-dayβ-HCG doubling number ≤1.49,the sensitivity was 1,the false negative rate was 0,thus avoiding missed diagnosis of adverse pregnancy to the maximum.In addition,when serumβ-HCG level=5,000-50,000IU/L,the daily increasing values of β-HCG varied significantly in patients with different pregnancy outcomes.If β-HCG daily increasing 3149.38IU/L as the cut-off value in predicting the pregnancy outcome,presenting a high diagnostic value,with sensitivity,specificity and AUC being 86%,75%and 0.842,respectively;when the daily increasing values of β-HCG≤689.42IU/L,the sensitivity was 1,the false negative rate was 0,thus avoiding missed diagnosis of adverse pregnancy to the maximum.When serum β-HCG level=50,000-100,000IU/L,the daily increasing values of β-HCG varied significantly in patients with different pregnancy outcomes.If β-HCG daily increasing 6163.99IU/L as the cut-off value in predicting the pregnancy outcome,presenting a high diagnostic value,with sensitivity,specificity and AUC being 90.2%,51.7%and 0.749,respectively;when the daily increasing values of β-HCG≤985.84IU/L,the sensitivity was 1,the false negative rate was 0,thus avoiding missed diagnosis of adverse pregnancy to the maximum.6.In the early pregnancy,except for 5 weeks of pregnancy,there was significant difference in E2 level between the pregnancy continuation group and the pregnancy loss group.At 7 weeks of pregnancy,when the cut-off value of E2 for predicting the pregnancy outcome was 467.01pg/ml,the E2 level had a certain diagnostic value in predicting the pregnancy loss,with the the sensitivity,the specificity and the AUC being 87.5%,49.1%and 0.722,respectively;when E2≤112.73pg/ml,the sensitivity was 1,the false negative rate was 0,thus avoiding missed diagnosis of adverse pregnancy to the maximum.At 8 weeks of pregnancy,when the cut-off value of E2 for predicting the pregnancy outcome was 790.96pg/ml,the E2 level had a certain diagnostic value in predicting the pregnancy loss,with the the sensitivity,the specificity and the AUC being 80.2%,68.2%and 0.741,respectively;when E2≤151.19pg/ml,the sensitivity was 1,the false negative rate was 0,thus avoiding missed diagnosis of adverse pregnancy to the maximum.7.In the early pregnancy,P level gradually increase with gestational age,the P level in the pregnancy continuation group was higher than that in the pregnancy loss group,but without significant difference.Patients were divided into high P group and low P group by taking P≤78 nmol/l（25 ng/ml）as the threshold.From 7 weeks of pregnancy,there was a significant difference in the distribution of pregnancy outcomes between the high P group and the low P group.8.As for syndrome elements of disease location,mixed disease location was mainly found in patients with threatened abortion,and spleen（82.1%）was the most frequent disease location,followed by kidney（60.7%）,heart（43.2%）and liver（34.0%）.There was no significant difference in the distribution of TCM syndrome elements of disease location concerning different pregnancy outcomes.9.As for syndrome elements of disease nature,mixed disease nature was mainly observed in patients with threatened abortion,and the frequency of heat was the highest（25%）,followed by dampness（20.0%）,blood deficiency（17.4%）,Qi deficiency（14.6%）,Qi stagnation（12.8%）,blood stasis（5.7%）and coldness（4.5%）.There was no significant difference in the distribution of TCM syndrome elements of disease nature regarding different pregnancy outcomes.[Conclusion]1.There were significant correlations of gestational age,previous abortion history,pregnancy mode with the pregnancy outcome,but no significant correlation was found for menstrual history and previous delivery history with the pregnancy outcome.2.In early pregnancy,there were significant differences in the levels of β-HCG and E2 between the pregnancy continuation group and the pregnancy loss group.The alternate-day β-HCG doubling number,the daily β-HCG increasing value and the E2 level were of great significance in predicting pregnancy outcome,and we found that the alternate-day β-HCG doubling number and the daily β-HCG increasing value showed a high diagnostic significance.Additionally,the lower the P level,the more attention should be paid to,from 7 weeks of pregnancy,if P≤78nmol/l,the pregnancy outcome will be poor.3.In patients with threatened miscarriage,the spleen is the most common syndrome elements of disease location,and the fever is the first major syndrome elements of disease nature.There was no significant correlation of disease location and disease nature for TCM syndrome elements with the pregnancy outcome,and differentiation of syndromes was still needed for predicting pregnancy outcomes in patients with threatened abortion in clinical practice. |
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